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Clinical Trials/NCT06303895
NCT06303895Not yet recruitingNot Applicable

How Acupuncture Therapy Improves Dysphagia in Parkinson's Patients: A Randomized Controlled Study

Muhammad0 sites80 target enrollmentStarted: March 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
80
Primary Endpoint
Penetration-Aspiration Scale-liquid

Study Overview

Brief Summary

This study is focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants.

Detailed Description

This study is focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants.

The study lasted 42 days (6 weeks) for each participant. Specifically, our main focus is on the study of Lianquan, Shanglianquan (depression between the hyoid bone and the lower border of the mandible), Yifeng, Fengchi, Wangu, Fengfu, Yamen, Neidaying (depression of 1 inch below the anterior margin of the mandible), Jinjin, Yuye, posterior pharyngeal wall (both sides of the uvula).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age >18 years.
  • Meeting the diagnostic criteria for Parkinson's disease.
  • Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
  • Water swallow test> Level
  • Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion Criteria

  • Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
  • History of mental diseases or use of antipsychotics.
  • Complicated with cognitive impairment or consciousness dysfunction.
  • Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.

Arms & Interventions

routine treatment+swallowing rehabilitation training+acupuncture therapy

Experimental

The group was given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.

Intervention: Routine rehabilitation training (Behavioral)

routine treatment+swallowing rehabilitation training+acupuncture therapy

Experimental

The group was given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.

Intervention: Swallowing rehabilitation training (Behavioral)

routine treatment+swallowing rehabilitation training+acupuncture therapy

Experimental

The group was given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.

Intervention: Acupuncture therapy (Procedure)

routine treatment+swallowing rehabilitation training

Active Comparator

The control was given routine treatment and swallowing rehabilitation training

Intervention: Swallowing rehabilitation training (Behavioral)

routine treatment+swallowing rehabilitation training

Active Comparator

The control was given routine treatment and swallowing rehabilitation training

Intervention: Routine rehabilitation training (Behavioral)

Outcomes

Primary Outcomes

Penetration-Aspiration Scale-liquid

Time Frame: Day 1 and Day 42

The Penetration-Aspiration Scale (PAS) was conducted under video fluoroscopic swallowing study. PAS is a standardized tool used to assess the safety of swallowing. The scale was developed to evaluate the entry of material into the airway (penetration) and the subsequent passage of material below the vocal folds (aspiration) during swallowing. The PAS scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration

Penetration-Aspiration Scale-paste

Time Frame: Day 1 and Day 42

The Penetration-Aspiration Scale (PAS) was conducted under video fluoroscopic swallowing study. PAS is a standardized tool used to assess the safety of swallowing. The scale was developed to evaluate the entry of material into the airway (penetration) and the subsequent passage of material below the vocal folds (aspiration) during swallowing. The PAS scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration.

Secondary Outcomes

  • Serum Albumin(Day 1 and Day 42)
  • body mass index(Day 1 and Day 42)
  • Prealbumin(Day 1 and Day 42)
  • Swallowing time(Day 1 and Day 42)
  • Hemoglobin(Day 1 and Day 42)
  • Swallowing Quality of Life(Day 1 and Day 42)

Investigators

Sponsor
Muhammad
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Muhammad

Research Director

Ahmadu Bello University Teaching Hospital

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